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Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China

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ClinicalTrials.gov Identifier: NCT01556165
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : December 23, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: rasagiline
Drug: placebo
Enrollment 130
Recruitment Details Outpatients aged 35 years or older, who had idiopathic Parkinson's disease and were not treated with levodopa or other antiparkinsonian medications, were recruited for this study from China.
Pre-assignment Details A Screening Visit was held approximately 28 days prior to group assignment (group assignment was held during the Baseline Visit). Patients who met each of the inclusion criteria and none of the exclusion criteria were eligible to participate in this study.
Arm/Group Title Placebo Rasagiline
Hide Arm/Group Description placebo: tablets, once daily, orally rasagiline: 1 mg/day, tablets, once daily, orally
Period Title: Overall Study
Started 65 65
Completed 53 58
Not Completed 12 7
Reason Not Completed
Adverse Event             5             3
Protocol Violation             0             3
Withdrawal of Consent             7             1
Arm/Group Title Placebo Rasagiline Total
Hide Arm/Group Description placebo: tablets, once daily, orally rasagiline: 1 mg/day, tablets, once daily, orally Total of all reporting groups
Overall Number of Baseline Participants 65 65 130
Hide Baseline Analysis Population Description
The all-patients-treated set (APTS) comprises all randomised patients who took at least one dose of IMP.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 65 participants 130 participants
59.5  (9.22) 58.5  (8.72) 59.0  (8.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
Female
25
  38.5%
30
  46.2%
55
  42.3%
Male
40
  61.5%
35
  53.8%
75
  57.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
65
 100.0%
65
 100.0%
130
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline to Week 26 in UPDRS Total Score
Hide Description The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.
Arm/Group Title Placebo Rasagiline
Hide Arm/Group Description:
placebo: tablets, once daily, orally
rasagiline: 1 mg/day, tablets, once daily, orally
Overall Number of Participants Analyzed 63 64
Mean (Standard Error)
Unit of Measure: units on a scale
-0.18  (0.98) -3.18  (0.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rasagiline
Comments This study was designed to show a trend, that is, to show a clinical difference in the primary efficacy analysis, at a two-sided significance level of 0.25. Assuming a difference between rasagiline and placebo of a 3-point change in the UPDRS total score and a standard deviation on the change from baseline of 7 points, a sample size of 60 patients per treatment group gave an 88% probability of showing a trend. LOCF (last observation carried forward) was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0254
Comments No adjustments for multiple comparisons were made.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.00
Confidence Interval (2-Sided) 75%
-4.53 to -1.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.32
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)
Hide Description The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.
Arm/Group Title Placebo Rasagiline
Hide Arm/Group Description:
placebo: tablets, once daily, orally
rasagiline: 1 mg/day, tablets, once daily, orally
Overall Number of Participants Analyzed 63 64
Mean (Standard Error)
Unit of Measure: units on a scale
0.08  (0.15) -0.54  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rasagiline
Comments LOCF (last observation carried forward) was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method ANCOVA
Comments The same ANCOVA methodology as for the primary endpoint was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.03 to -0.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)
Hide Description The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.
Arm/Group Title Placebo Rasagiline
Hide Arm/Group Description:
placebo: tablets, once daily, orally
rasagiline: 1 mg/day, tablets, once daily, orally
Overall Number of Participants Analyzed 63 64
Mean (Standard Error)
Unit of Measure: units on a scale
0.25  (0.38) -0.43  (0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rasagiline
Comments LOCF (last observation carried forward) was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1963
Comments [Not Specified]
Method ANCOVA
Comments The same ANCOVA methodology as for the primary endpoint was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-1.70 to 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.52
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)
Hide Description The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.
Arm/Group Title Placebo Rasagiline
Hide Arm/Group Description:
placebo: tablets, once daily, orally
rasagiline: 1 mg/day, tablets, once daily, orally
Overall Number of Participants Analyzed 63 64
Mean (Standard Error)
Unit of Measure: units on a scale
-0.52  (0.68) -2.23  (0.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rasagiline
Comments LOCF (last observation carried forward) was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0641
Comments [Not Specified]
Method ANCOVA
Comments The same ANCOVA methodology as for the primary endpoint was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.71
Confidence Interval (2-Sided) 95%
-3.52 to 0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.91
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Onset of Levodopa Therapy
Hide Description It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
Time Frame Baseline to Week 26
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Levodopa Administration Within 26 Weeks
Hide Description It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
Time Frame Baseline to Week 26
Outcome Measure Data Not Reported
Time Frame 30 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Rasagiline
Hide Arm/Group Description placebo: tablets, once daily, orally rasagiline: 1 mg/day, tablets, once daily, orally
All-Cause Mortality
Placebo Rasagiline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Rasagiline
Affected / at Risk (%) Affected / at Risk (%)
Total   4/65 (6.15%)   0/65 (0.00%) 
Eye disorders     
Cataract * 1  1/65 (1.54%)  0/65 (0.00%) 
Injury, poisoning and procedural complications     
Road traffic accident * 1  1/65 (1.54%)  0/65 (0.00%) 
Thoracic vertebral fracture * 1  1/65 (1.54%)  0/65 (0.00%) 
Musculoskeletal and connective tissue disorders     
Spinal osteoarthritis * 1  1/65 (1.54%)  0/65 (0.00%) 
Psychiatric disorders     
Major depression * 1  1/65 (1.54%)  0/65 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rasagiline
Affected / at Risk (%) Affected / at Risk (%)
Total   6/65 (9.23%)   8/65 (12.31%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  3/65 (4.62%)  4/65 (6.15%) 
Nervous system disorders     
Parkinson's disease * 1  4/65 (6.15%)  5/65 (7.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study director
Organization: Email contact via H. Ludbeck A/S
EMail: LundbeckClinicalTrials@lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01556165    
Other Study ID Numbers: 13485A
First Submitted: March 13, 2012
First Posted: March 16, 2012
Results First Submitted: December 4, 2014
Results First Posted: December 23, 2014
Last Update Posted: December 23, 2014